Experts predict challenges as the life sciences sector adapts to the EU AI Act, which aims to protect citizens while regulating AI use in drug development. The regulation categorizes AI usage by risk levels and is set to fully enforce guidelines by August 2026.
The World Health Organization (WHO) has launched a global initiative to establish a unified governance framework for artificial intelligence (AI) in healthcare, focusing on safety, ethics, and accessibility. This initiative aims to support low- and middle-income countries in effectively integrating AI into their health systems while addressing ethical concerns and regulatory challenges.
The AI regulatory landscape has undergone significant changes, with the US and UK adopting more pro-innovation approaches while the EU has shifted its focus as well. This evolving environment presents both opportunities and challenges for ensuring safety and public trust in health-related AI technologies.
The UK is working on new regulations to better govern software and AI in medical devices, with the MHRA focusing on principles that ensure safety and efficacy. As innovation accelerates, the MHRA has initiated programs like the AI Airlock pilot to streamline the path for AI medical devices to reach the market.
A new bill, the Healthy Technology Act of 2025, aims to allow artificial intelligence (AI) to have prescribing privileges if authorized by states and approved by the FDA. While some experts see potential in AI for healthcare, they emphasize the need for more research before AI can autonomously prescribe medications.
The EU AI Act is now partially in effect, requiring hospitals and vendors to comply by August 2026, with strict regulations and potential fines for noncompliance. Experts emphasize the need for transparency and education in deploying AI tools to ensure patient safety and effective healthcare outcomes.
The paper discusses the challenges of moral accountability and safety assurance in the use of artificial intelligence-based clinical tools in healthcare. It emphasizes the need to update our understanding of accountability due to the opaque decision-making processes of these systems and suggests involving AI developers in the assessment of patient harm.
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